OUTSTEP-1

Enrolling by invitation

Characteristics and Treatment Experiences of Individuals Using Injectable Semaglutide for Weight Management, a Cross-sectional Time-series Analysis, Multi-country Study.

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

2,546

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Description of characteristics•EQ-5D index•BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07154238

Org study IDNN9536-8412

Secondary IDU1111-1314-6149WHO

Timeline

Milestones

Study first posted2025-09-04actual

Study start2025-09-26actual

Last update posted2025-11-25actual

Primary completion2026-09-30estimated

Study completion2026-09-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

This study will collect quantitative and qualitative data from individuals treated with injectable semaglutide for weight management in real-world settings. The study will include two groups of participants: 1. Individuals who belong to or are recruited to an opt-in panel in the countries of interest and who have initiated injectable semaglutide for weight management. They will be classified according to the time when they first initiated treatment with injectable semaglutide for weight management. 2. HCPs who prescribe injectable semaglutide for weight management will be recruited from an existing opt-in panel in the countries of interest.

Inclusion criteria

•For an eligible participant (individuals initiated on injectable semaglutide for weight management), all inclusion criteria must be answered "yes".

1. Electronically provided consent obtained before any study-related activities can be completed.

2. Age above or equal to 18 years at the time of providing informed consent.

3. Reside in a participating country: Australia, Germany, United Arab Emirates (UAE) and Spain.

4. Have been prescribed and initiated injectable semaglutide for weight management prior to study screening.

•For an eligible participant (HCPs), all inclusion criteria must be answered "yes".

1. Electronically provided consent obtained before any study-related activities can be completed.

2. Practice in a participating country: Australia, Germany, UAE, and Spain.

3. See at least 150 patients for any condition per month; priority given to those who treat at least 200 patients for any condition per month.

4. Treat at least 10 adult patients per month for weight management.

5. Prescribe anti-obesity medications (AOMs) to their patients they personally treat for weight management/obesity care; priority given to those who treat at least 10% of the patients they personally treat for weight management/obesity care with anti-obesity medications (AOMs).

6. Prescribe injectable semaglutide for weight management.

7. Be a specialty of interest (varies by country); mix of primary care, specialists such as Endocrinologists, Diabetologists, Nutrition Specialists, Obesity Specialists and others.

Exclusion criteria

•For an eligible participant (individuals initiated on injectable semaglutide for weight management), all exclusion criteria must be answered "no".

1. Unwillingness or language barriers precluding adequate understanding or cooperation.

2. Is currently or planning to become pregnant in next six months.

3. Is taking injectable semaglutide for Type 2 diabetes management only.

•For an eligible participant (HCPs), all exclusion criteria must be answered "no".

1. Prior participation in this study. Participation is defined as having given informed consent and submitting responses to an interview.

2. Unwillingness or language barriers precluding adequate understanding or cooperation.

3. Only treats patients under 18 years of age.

Endpoints (38)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

Other clinical outcomes

Weight & body composition

2 endpoints

Primary/protocol endpoint

Individual-reported change in BMI since initiation

Time frame:At the time of survey response (Day 1)

BMI, change

change from baseline, improvement

Primary/protocol endpoint

Individual-reported change in weight since initiation

Time frame:At the time of survey response (Day 1)

Body weight, absolute change (kg)

change from baseline, improvement

Patient-reported / QoL

29 endpoints

Primary/protocol endpoint

Description of the experience of individuals initiated on injectable semaglutide for weight management through personal perception of physical and mental health and self-reported QoL

Time frame:At the time of survey response (Day 1)

EQ-5D index

descriptive

Primary/protocol endpoint

Individual-reported achievement of weight loss goal

Time frame:At the time of survey response (Day 1)

PGI, change

threshold achievement, improvement

Primary/protocol endpoint

Individual-reported changes in daily life since initiation on injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Treatment expectation of individuals initiated on injectable semaglutide of ability to achieve weight loss goal using injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Expectation for length of time of treatment to desired result from date of initiation on injectable semaglutide at baseline

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Expectation of individuals initiated on injectable semaglutide for weight management who believe they will have greater success in achieving their weight loss with the use of injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Expected benefits of injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Satisfaction with weight loss since initiation

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Overall satisfaction with injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive, improvement

Secondary/protocol endpoint

Individual-reported changes in perception of injectable semaglutide since initiation

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes of individuals related to obesity or weight related stigmatization or discrimination prior to/since/due to initiation on injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes of individuals initiated on injectable semaglutide for weight management related to obesity as a chronic disease

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes of individuals initiated on injectable semaglutide for weight management related to weight loss being their responsibility

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Attitudes of individuals initiated on injectable semaglutide for weight management related to weight loss being more likely with use of prescription medication for weight loss (AOMs)

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Degree of knowledge of individuals initiated on injectable semaglutide for weight management related to how prescription weight loss medications (AOMs) work in the body

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes of individuals initiated injectable semaglutide for weight management related to the necessity to make lifestyle changes in addition to initiating injectable semaglutide for weight loss or weight management to achieve their weight loss goals

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes of individuals who initiated on injectable semaglutide for weight management relating to ease of maintaining lifestyle changes (e.g., eating a healthy diet and getting regular exercise) since initiating on injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Individual-reported change in overall knowledge of how AOMs work from initiation on injectable semaglutide to present day

Time frame:At the time of survey response (Day 1)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Attitudes related to viewing obesity as a chronic disease

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes related to belief weight loss is solely an individual's responsibility

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes related to belief weight loss requires use of prescription medication for weight loss (AOMs)

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Attitudes related to belief individuals must make lifestyle changes in addition to initiating on injectable semaglutide for weight loss or weight management to achieve their weight loss goals

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Attitudes related to belief individuals will have greater success in achieving their weight loss goals with use of injectable semaglutide

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Future planned use of injectable semaglutide (among current users)

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Likelihood to resume injectable semaglutide (specifically for weight management) after formal discontinuation and reasons

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Individual-reported likelihood of continuation on injectable semaglutide until achieve goal weight and reasons

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Likelihood of continuation on injectable semaglutide after achieving weight loss goal and reasons

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Treatment pause initiated by individual and reasons

Time frame:At the time of survey response (Day 1)

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Among those with low likelihood to use injectable semaglutide after discontinuation, potential use of another AOM

Time frame:At the time of survey response (Day 1)

categorical status, descriptive

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Reasons for discontinuation (among those who discontinued)

Time frame:At the time of survey response (Day 1)

Discontinuation due to AE

descriptive

Secondary/protocol endpoint

Treatment pause initiated by HCP and reasons

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint

Number of treatment pauses

Time frame:At the time of survey response (Day 1)

event count, descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Attitudes related to level of comfort prescribing AOMs and injectable semaglutide specifically for weight management

Time frame:At the time of survey response (Day 1)

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Description of characteristics, including clinical, demographic and physical characteristics, among individuals initiated on injectable semaglutide for weight management

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Behaviours of individuals initiated on injectable semaglutide for weight management related to making lifestyle changes in addition to initiating on injectable semaglutide for weight loss or weight management to achieve their weight loss goals

Time frame:At the time of survey response (Day 1)

descriptive

Secondary/protocol endpoint/low confidence

Reasons for length of adherence

Time frame:At the time of survey response (Day 1)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.